Just in time for the holidays, the Centers for Medicare and Medicaid Services (“CMS”) issued the Contract Year 2024 Proposed Rule for Medicare Advantage organizations (“MAOs”) and Part D sponsors (the “Proposed Rule”). The Proposed Rule includes changes on an array of topics including: Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, behavioral health services, identification of overpayments, requirements for valid contract applications, and formulary changes.
Last month, the U.S. Department of Health and Human Services Office of Inspector (“OIG”) released a report that studied prior authorization denials and payment denials by Medicare Advantage Organizations (“MAOs”)…Continue Reading HHS OIG Report On Prior Authorizations Under Medicare Advantage
It’s official: the Department of Veterans Affairs (“VA”) Medical Surgical Prime Vendor (“MSPV”) 2.0 Program is no more. The VA has announced that it will not revive MSPV 2.0 following several unusually painful protests at the U.S. Court of Federal Claims (see our prior blogs here and here). Instead the VA will move on to MSPV-“Z”. Generally speaking, there seems to be little difference between “2.0” and “Z,” except that some division of geographies may change. But importantly, the VA plans to make clear in the MSPV-Z solicitation—which currently is in the works—whether and when it will transfer the contracts’ requirements to the Defense Logistics Agency (“DLA”), an issue that has drawn significant criticism to date. The VA says it is developing the business case for the transfer, and the business case analysis will determine both whether it will happen at all, and how the VA will execute the transfer. In the meantime, the VA will extend the current bridge contracts under MSPV-Next Generation (“MSPV-NG”) for a full year, running December 2021 to December 2022, while the VA (and likely the DLA) get their ducks in a row.
Continue Reading MSPV 2.0 Is Dead – Long Live MSPV
Ignore our prior prediction—the U.S. Court of Federal Claims definitely is NOT remanding the protest by Medline Industries, Inc. (“Medline Protest’) to the agencies for corrective action. In a surprisingly scathing opinion issued June 22, 2021 by Judge David A. Tapp, the court made one thing very clear—the Department of Veterans Affairs’ (“VA”) transfer of its Medical Surgical Prime Vendor (“MSPV 2.0”) requirements to the Defense Logistics Agency (“DLA”) is dead on arrival. After issuing a brief order on June 17 denying remand to the agencies for corrective action, the court detailed its reasoning in an opinion issued in a parallel protest filed by Owens & Minor Distribution, Inc. challenging (slightly) different aspects of the shifting MSPV 2.0 procurement (“O&M Protest”). The government had moved for remand in both protests, and because the Medline Protest and O&M Protest involved the same parties and many common operative facts, the court issued a single opinion denying remand in both—and telegraphing that the outlook for the government in both cases is grim. Piling on, the court took a few shots at the government for its litigation conduct and (more generally) its lack of acquisition planning.
Continue Reading Duck Hunt – The VA Cannot Escape The Medline Protest, And Takes A Few Shots In The Process
The U.S. Department of Veterans Affairs (“VA”) Medical Surgical Prime Vendor (“MSPV”) 2.0 Program (discussed previously here and here) has yet to make it off the ground, but in March 2021 the VA announced plans to eliminate the program by September 2023 and instead purchase from the Defense Logistics Agency’s (“DLA”) separate MSPV catalog. The VA and DLA MSPV programs are how the VA and DLA (separately) purchase most of their medical, surgical, and laboratory equipment for care centers across the country (and abroad, in the case of DLA). The VA and DLA have been exploring the possibility of consolidation since at least January 2019, but many vendors relied on the VA’s representations that it would not make any decisions on potential consolidation until at least 2025. So when the VA informed stakeholders of its new September 2023 target, Medline Industries, Inc. (“Medline”), one of the prime vendor awardees under the VA’s MSPV 2.0 Program, responded by filing a bid protest at the U.S. Court of Federal Claims. On May 28, 2021, the VA and DLA decided to take corrective action, asking the Court for six months to re-evaluate the issues raised by the protest. It seems that the government did not have all of its ducks in a row prior to announcing the targeted transition.
Continue Reading Ducks (Not) in a Row – VA Agrees to Take Corrective Action in Transitioning MSPV 2.0 Requirements to DLA
The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President…
Continue Reading “Buy American” Update: Essential Medicines May Continue to Come From Abroad (For Now)
The Secretary of the U.S. Department of Health and Human Services recently added government contractors to the list of entities eligible for immunity from liability under the Secretary’s March 17, 2020, Public Readiness and Emergency Preparedness Act (“PREP Act”) declaration. The PREP Act protects individuals and companies from liability for death or other tort-like harm in connection with the pandemic response, except for cases involving “willful misconduct.” Under the recent amendment, government contractors acting with authorization from an executive department or agency—or who could be so authorized—are protected from liability when they prescribe, administer, deliver, distribute, or dispense Covered Countermeasures, as long as they meet the other requirements of the Act. Covered Countermeasures could include the COVID-19 vaccine or personal protective equipment like respirators. We wrote previously about the evolving list of masks and respirators qualifying as Covered Countermeasures here, here, and here. …
Continue Reading Authorized Government Contractors Now Covered Persons Under the PREP Act
On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944), which required the U.S. government to purchase “essential” medicines and medical supplies produced domestically, rather than abroad. We previously wrote about this Executive Order in August (available here), expecting that once the list was issued, government agencies would begin implementing the “Buy American” priorities for these products and materials. The FDA has identified around 227 drugs and 96 devices, along with their respective critical inputs or active ingredients, that the FDA believes “are medically necessary to have available at all times” for the public health. Agencies across the federal government should now begin making non-competitive awards “to the maximum extent permitted by law,” for drugs and medical supplies on this list that are produced in the United States. We have yet to see how agencies will implement these requirements in regulations or class deviations, but publication of this list is an important first step in implementing the rest of the “Buy American” priorities in the Executive Order. …
Continue Reading “Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order
Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational Safety and Health (“NIOSH”) through the Families First Coronavirus Response Act, and the later expanded scope of that protection provided by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act and amended PREP Act declaration by Department of Health and Human Services. Until recently, the list of devices eligible for liability immunity seemed to be continuously growing as the COVID-19 public health response required more and more PPE. But last week, the Food and Drug Administration (“FDA”) took a significant step back, retracting its Emergency Use Authorization (“EUA”) for respirators from 75 manufacturers in China, which previously had been approved for use in the response to COVID-19. This retraction has the additional effect of disqualifying government contractors, and other companies that distribute newly unauthorized respirators, from PREP Act immunity in connection with these devices.
Continue Reading Not So Fast – FDA Retracts Authorization for Some Respirators Made in China
All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public Health Service Act, and their manufacturers and distributors are eligible for immunity from suits for injury and death resulting from use of the masks in the public health response to COVID-19. The Secretary for the Department of Health and Human Services (“HHS”) issued an updated PREP Act declaration implementing this addition to the covered countermeasures eligible for PREP Act immunity, with retroactive effect to March 27, 2020.
Continue Reading PREP Act Update: All NIOSH-Approved Respirators Now Are Covered Countermeasures Eligible for Immunity